At a Glance
- Tasks: Lead the technical strategy for manufacturing processes and drive innovation in product delivery.
- Company: Join a forward-thinking company committed to excellence in manufacturing operations.
- Benefits: Enjoy a competitive salary, generous holiday, and a strong pension contribution.
- Other info: Be part of a diverse team with a focus on continuous improvement and quality culture.
- Why this job: Make a significant impact on product launches and shape the future of manufacturing.
- Qualifications: Bachelor’s degree in relevant field and proven experience in tech transfers and team leadership.
The predicted salary is between 60000 - 75000 £ per year.
Lead the site’s translation and delivery of manufacturing processes from Process Development to Manufacturing Operations, acting as the technical voice for Manufacturing.
Responsibilities
- Own the end‑to‑end technical strategy for new product introduction, tech transfer, scale‑up, PPQ, launch, and commercial stewardship to ensure safe, compliant, and cost‑effective manufacturing.
- Provide strategic leadership for MSAT across New Product Introduction, Process Engineering, and Process Lifecycle teams, setting standards, operating model, and governance.
- Lead and develop multi‑disciplinary teams, set objectives, develop talent, and build a high‑performance culture.
- Deliver robust tech transfer packages, including equipment/facility fit, URS/FAT/SAT, IQ/OQ, PPQ protocols/reports, and launch readiness.
- Serve as senior technical authority for commercial processes, owning CPV strategy, process performance, and product technical books.
- Drive portfolio prioritisation and resourcing for NPIs, site transfers, scale‑ups, and lifecycle changes based on risk/benefit and business value.
- Lead investigations for major deviations / OOS / OOT, ensuring root‑cause analysis, scientifically justified CAPAs, and rigorous change control.
- Own site contamination control strategy, cleaning development and validation associated with new product introduction.
- Champion inspection readiness; represent MSAT during customer/regulatory audits and support CMC dossier content and post‑approval commitments.
- Own technical risk management and process safety within tech transfer; foster a proactive quality, EHS, and continuous improvement culture.
Qualifications
- Bachelor’s degree in a relevant discipline (e.g., Chemical/Biochemical Engineering, Life Sciences).
- Proven delivery of tech transfers, PPQ, and commercial lifecycle management in GMP environments.
- Demonstrated success building and leading multi‑disciplinary teams with strong coaching and succession planning.
- Experience interfacing with regulatory agencies and leading customer interactions and audits.
- Deep knowledge of contamination control, cleaning validation, CPV, data integrity, and change control.
- Strong portfolio governance, stage‑gate discipline, and cross‑functional collaboration with QA, QC/Analytical, Manufacturing, Supply Chain, Regulatory CMC, and Digital/Automation.
Benefits
- Competitive salary and annual incentive plan.
- Up to 21% contribution to pension.
- 35 days holiday (excluding public holidays).
- Significant autonomy and impact on capacity, compliance, and speed‑to‑launch.
Equal Opportunity Employer
We are committed to providing equal opportunities in hiring, promotion and advancement, compensation, benefits, and training regardless of nationality, age, gender, sexual orientation or gender identity, race, ethnicity, religion, political creed, ideology, national or social origin, disability, veteran status, etc.
Senior Director, MSAT in Billingham employer: FLBK FUJIFILM Diosynth Biotechnologies UK Limited
As a Senior Director in MSAT at our Billingham site, you will be part of a dynamic and inclusive work culture that prioritises employee growth and development. We offer competitive salaries, generous holiday allowances, and a robust pension contribution, all while providing significant autonomy to influence manufacturing processes and drive innovation. Join us to lead multi-disciplinary teams in a role that not only challenges you but also rewards your contributions to safe and compliant manufacturing practices.
Contact Details:
FLBK FUJIFILM Diosynth Biotechnologies UK Limited Recruitment Team
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✨Understand the Science
Make sure you brush up on key pharmaceutical concepts and recent developments in the industry. You might get asked some technical questions during the interview at FLBK FUJIFILM Diosynth Biotechnologies UK Limited that show your grasp of drug development processes or regulatory requirements, so be ready to discuss them clearly.
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